MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT¿ PLUS; STENT, CORONARY, DRUG-ELUTING

Model Number H7493911416400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Congestive Heart Failure (1783); Death (1802); Dyspnea (1816); Non specific EKG/ECG Changes (1817); Edema (1820); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Ventricular Tachycardia (2132)

Event Date 07/05/2015

Event Type  Death  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id 2134265-2016-00486.(b)(4).It was reported that myocardial infarction, congestive heart failure and patient death occurred.In (b)(6) 2013, the patient was referred for cardiac catheterization.Subsequently, the index procedure was performed.The target lesion was a de novo lesion located in the distal portion of the saphenous vein graft (svg) to mid left anterior descending artery (lad) with 95% stenosis and was 32mm long with a reference vessel diameter of 4.00mm.The target lesion was treated with predilation and placement of two overlapping 4.00mmx16mm promus element¿ plus stents.Following post dilation, residual stenosis was 0%.The next day, the patient was discharged on aspirin and ticagrelor.In (b)(6) 2015, the patient presented with history of prolonged ischemic chest discomfort and worsening angina which was unrelieved by nitrates.The patient also had worsening lower extremity edema, nonsustained ventricular tachycardia and ischemic cardiomyopathy with decompensated congestive heart failure (chf).Cardiac enzymes are elevated and the patient was subsequently diagnosed with non-st segment myocardial infarction.The patient was referred for another cardiac catheterization.Five days later, coronary angiography and chest x-ray were performed.Chest x-ray showed some mild chft.Subsequently the patient was recommended for medical treatment.Three days later, the event was considered resolved and subject was discharged on aspirin and clopidogrel.In (b)(6) 2015, the patient presented with profound shortness of breath associated with weakness along with clinical chf and was hospitalized on the same day.Subsequently the subject was administered with lasix but without any improvement of his symptoms.The patient was also placed on milrinone but he experienced non-sustained ventricular tachycardia due to which milrinone was discontinued and there was no interventional solution available, since the patient had achieved maximum benefits possible with medications.Electrocardiogram showed ventricular pacing.Cardiac enzymes were noted to be negative while his chest x-ray showed hyperinflation consistent with chronic obstructive pulmonary disease (copd) and some minimal vascular congestion.After discussion with the patient and his wife regarding the poor prognosis, do not resuscitate (dnr) status was initiated and it was recommended to place the patient on hospice care.Three days later, the event was considered resolved and patient was discharged on aspirin and clopidogrel.Eleven days post discharge, the patient died.The primary cause of death was congestive heart failure.Autopsy was not performed.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the events were not related to both devices as the study stents was noted to be patent.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5429833
• MDR Text Key: 37957692
• Report Number: 2134265-2016-00485
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2013
• Device Model Number: H7493911416400
• Device Catalogue Number: 39114-1640
• Device Lot Number: 15633552
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2016
• Initial Date FDA Received: 02/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 73 YR